FDA streamlines “compassionate use” application process

6th June 2016

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The US Food and Drug Administration (FDA) has finalised its efforts to streamline the “compassionate use” process, used by physicians to access investigational drugs and biologics for patients with limited treatment options. A statement from Robert Califf, the deputy commissioner of the FDA’s Office of Medical Products and Tobacco has been released, detailing the efforts.

The FDA have released the final “Individual Patient Expanded Access Investigational New Drug Application” form (FDA 3926), as well as two final guidance documents. “One is in a question and answer format and explains what expand access is, when and how to request expanded access, and the type of information that should be included in requests. The other explains the regulations regarding how patients may be charged for investigational drugs,” explains Califf in the statement.

The new FDA 3926 form is intended to offer a much shorter, streamlined replacement for the previous form for individual patient expanded access requests. The new form, Califf claims, should take about 45 minutes to complete.

In the statement, Califf says, “Access to investigational treatments requires the active cooperation of the FDA, industry, and health care professionals in order to be successful. But we know that navigating that process can be challenging and time-consuming, and we are committed to reducing the procedural burdens on physicians and patients whenever possible.”